SI2512450T1 - Suh sestavek rastnega hormona, tranzientno vezanega na polimerni nosilec - Google Patents

Suh sestavek rastnega hormona, tranzientno vezanega na polimerni nosilec Download PDF

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SI2512450T1
SI2512450T1 SI201031679T SI201031679T SI2512450T1 SI 2512450 T1 SI2512450 T1 SI 2512450T1 SI 201031679 T SI201031679 T SI 201031679T SI 201031679 T SI201031679 T SI 201031679T SI 2512450 T1 SI2512450 T1 SI 2512450T1
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rhgh
growth hormone
polymer prodrug
syndrome
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Grethe Norskov Rasmussen
Susanne Kindermann
Harald Rau
Thomas Wegge
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Ascendis Pharma Endocrinology Division A/S
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    • A61K38/27—Growth hormone [GH] (Somatotropin)
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
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    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly

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Claims (20)

  1. Suh sestavek rastnega hormona, tranzientno vezanega na polimerni nosilec Patentni zahtevki
    1. Postopek izdelave suhega sestavka, ki obsega terapevtsko učinkovito količino rhGH polimernega predzdravila in en ali več lioprotektantov, kjer je rastni hormon tranzientno vezan na polimerni nosilec, pri čemer ima rhGH polimerno predzdravilo kemijsko strukturo, prikazano v (A), kjer
    HN-rhGH predstavlja rhGH ostanek, vezan na tranzientni linker; Rl, R2, R3, R4 in R5 so izbrani neodvisno izmed vodika, metila, etila, propila, izopropila, butila, izobutila, terc. butila; PEG je vodotopen polietilen glikolni polimer, ki vsebuje vsaj 50 mas. % etilen oksidnih enot vezanih na tranzientni linker; n = 1 ali 2; in X je izbran izmed C1 do C8 alkila ali C1 do C12 heteroalkila; pri čemer postopek obsega stopnje (i) pomešanje rhGH polimernega predzdravila s trehalozo dihidratom in jantarno kislino, da dobimo sestavek, ki obsega rhGH polimerno predzdravilo 10-300 mg/ml jantarna kislina 5-50 mM trehaloza dihidrat 25-850 mg/ml, (ii) naravnavo pH sestavka stopnje (i) na pH v območju od pH 4,5 do pH 5,5 s tris, (iii) prenos količin zmesi iz stopnje (i), ki so ekvivalentne želenemu številu odmerkov, v ustrezne komore vsebnika, (iv) sušenje zmesi in (v) zatesnitev vsebnika; pri čemer se lahko vrstni red stopenj (ii) in (iii) zamenja.
  2. 2. Postopek po zahtevku 1, kjer je del
    iz formule (A) izbran iz skupine, ki jo sestavljajo
  3. 3. Postopek po zahtevku 1 ali 2, kjer je del
    iz formule (A) izbran iz skupine, ki jo sestavljajo
  4. 4. Postopek po katerem koli od zahtevkov od 1 do 3, kjer ima del
    iz formule (A) naslednjo strukturo
    kjer je vsak c neodvisno celo število od 250 do 750.
  5. 5. Postopek po katerem koli od zahtevkov od 1 do 4, kjer je hGH polimerno predzdravilo izbrano iz skupine, ki jo sestavljajo
    , iO0 do 125; kjer je m celo število do 200 do 250 in je n celo število do 1
    kjer je n celo število od 400 do 500;
    kjer je n celo število od 400 do 500; in
    kjer je n celo število od 400 do 500.
  6. 6. Postopek po katerem koli od zahtevkov od 1 do 5, kjer je vsaj 30 % vseh delov rastnega hormona v sestavku PEGiliranih na položaju Lysl58.
  7. 7. Postopek po katerem koli od zahtevkov od 1 do 6, kjer sestavek stopnje (i) obsega rhGH polimerno predzdravilo 10-300 mg/ml jantarna kislina 5-50 mM trehaloza dihidrat 30-150 mg/ml.
  8. 8. Postopek po katerem koli od zahtevkov od 1 do 7, kjer sestavek stopnje (i) obsega rhGH polimerno predzdravilo 10-300 mg/ml jantarna kislina 5-50 mM trehaloza dihidrat 50-100 mg/ml.
  9. 9. Postopek po katerem koli od zahtevkov od 1 do 8, kjer sestavek stopnje (i) obsega rhGH polimerno predzdravilo 30-60 mg/ml jantarna kislina 10 mM trehaloza dihidrat 70-85 mg/ml.
  10. 10. Postopek po katerem koli od zahtevkov od 1 do 9, kjer je stopnja (iv) izvedena z liofilizacijo.
  11. 11. Postopek po katerem koli od zahtevkov od 1 do 10, kjer je vsebnik dvokomoma brizga, ki ima prvo komoro z zmesjo, pri čemer postopek nadalje obsega stopnjo • polnjenja druge komore z rekonstitucijsko raztopino pred zatesnitivijo vsebnika.
  12. 12. Postopek priprave rekonstituiranega sestavka, ki obsega terapevtsko učinkovito količino rhGH polimernega predzdravila in en ali več lioprotektantov, kjer je rastni hormon tranzientno vezan na polimerni nosilec, pri čemer postopek obsega stopnje • izvedbo postopka po katerem koli od zahtevkov od 1 do 11, ki ima za rezultat suh sestavek; in • kontaktiranje suhega sestavka z rekonstitucijsko raztopino; kjer rekonstruiran sestavek obsega rhGH polimerno predzdravilo 10-300 mg/ml jantarna kislina 5-50 mM trehaloza dihidrat 25-850 mg/ml, in ima pH, ki sega od pH 4,5 do pH 5,5.
  13. 13. Rekonstruiran sestavek, ki obsega terapevtsko učinkovito količino rhGH polimernega predzdravila in en ali več lioprotektantov, kjer je rastni hormon tranzientno vezan na polimerni nosilec, pri čemer se sestavek lahko dobi s postopkom po katerem koli od zahtevkov od 1 do 11.
  14. 14. Rekonstruiran sestavek po zahtevku 13, kjer rekonstituiran sestavek obsega rhGH polimerno predzdravilo 10-300 mg/ml jantarna kislina 5-50 mM trehaloza dihidrat 30-150 mg/ml, in ima pH, ki sega od pH 4,5 do pH 5,5.
  15. 15. Rekonstituiran sestavek po zahtevku 13 ali 14, kjer rekonstituiran sestavek obsega rhGH polimerno predzdravilo 30-60 mg/ml jantarna kislina 10 mM trehaloza dihidrat 70-85 mg/ml, in ima pH, ki sega od pH 4,5 do pH 5,5.
  16. 16. Rekonstituiran sestavek po katerem koli od zahtevkov od 13 do 15, kjer rekonstituiran sestavek obsega tudi en ali več konzervansov in/ali antimikrobnih sredstev.
  17. 17. Rekonstituiran sestavek po katerem koli od zahtevkov od 13 do 16, kjer je rekonstitucijska raztopina sterilna voda, ki vsebuje 0,7-1,1 % benzilalkohola.
  18. 18. Rekonstituiran sestavek po katerem koli od zahtevkov od 13 do 16, kjer rekonstitucijska raztopina vsebuje 0,2-0,4 % krezola.
  19. 19. Rekonstituiran sestavek po katerem koli od zahtevkov od 13 do 18, kjer rekonstituiran sestavek nadalje obsega en ali dva ekscipienta.
  20. 20. Rekonstituiran sestavek po katerem koli od zahtevkov od 13 do 19 za uporabo v zdravljenju ali preprečevanju bolezni in motenj, izbranih iz skupine, ki jo sestavljajo pomanjkanje rastnega hormona, pomanjkanje rastnega hormona z nastopom pri odraslem; Turnerjev sindrom; Prader-Willijev sindrom; sindrom kratkega črevesja; kronična ledvična insuficienca; majhnost za gestacijsko starost ("small for gestational age")\ AIDS trošenje ("MOS-wasting"); zaščita pred staranjem; revmatoidni artritis; idiopatična majhna postava, homeobox gen za majhno postavo ("short stature homeobox gene")', somatopavza; majhna postava, povezana s podaljšano uporabo steroidov, Aarskogov sindrom; kronična ledvična bolezen; juvenilni revmatoidni artritis; cistična fibroza; HlV-infekcija pri otrocih, ki prejemajo HAART zdravljenje; majhna postava pri otrocih, rojenih z zelo nizko porodno težo, ki pa so majhni za gestatcijsko starost; skeletna displazija; hipohondroplazija, ahondroplazija; idiopatična majhna postava; pomanjkanje rastnega hormona pri odraslih, frakture v dolgih kosteh ali frakture dolgih kosti; fraktura v gobastih kosteh ali fraktura gobastih kosti; pacienti po operaciji kit ali ligamentov; distrakcijska osteogeneza; motnje, ki so rezultat zamenjave kolka ali diska; popravilo meniskusa; spinalne fuzije ali fiksacija protez; motnje, ki so rezultat fiksiranja osteosinteznega materiala; nezaraščanje ali nepravilno zaraščanje fraktur; motnje, ki so rezultat osteotomije; motnje, ki so rezultat implantacije vsadka; degeneracija sklepnega hrustanca v kolenu, povzročena s travmo ali artritisom; osteoporoza pri pacientih s Tumeijevim sindromom; osteoporoza pri moških; odrasli pacienti s kronično dializo; slaba prehrana, povezana s kardiovaskularno boleznijo pri odraslih pacientih s kronično dializo; reverzija kaheksije pri odraslih pacientih s kronično dializo; rak pri odraslih pacientih s kronično dializo; kronična obstraktivna pljučna bolezen pri odraslih pacientih s kronično dializo; HIV pri odraslih pacientih s kronično dializo; starejši odrasli pacienti s kronično dializo; kronična ledvična bolezen pri odraslih pacientih s kronično dializo; sindrom utrujenosti pri odraslih pacientih s kronično dializo; Crohnova bolezen; poslabšana jetrna funkcija; moški s HIV infekcijami; centralna debelost; s HIV povezan lipodistrofični sindrom; moška neplodnost; pacienti po veliki elektivni operaciji, detoksifikacija od alkohola/drog ali nevrološka travma; staranje; šibak starostnik; osteoartritis; travmatsko poškodovan hrustanec; erektilna disfunkcija; fibromialgija; motnje spomina; depresija; travmatska možganska poškodba; subarahnoidna krvavitev; zelo nizka porodna teža; metabolni sindrom; glukokortikoidna miopatija; in majhna postava zaradi glukokortikoidnega zdravljenja pri otrocih.
SI201031679T 2009-12-15 2010-12-15 Suh sestavek rastnega hormona, tranzientno vezanega na polimerni nosilec SI2512450T1 (sl)

Applications Claiming Priority (3)

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EP09179335 2009-12-15
EP10790843.6A EP2512450B1 (en) 2009-12-15 2010-12-15 Dry growth hormone composition transiently linked to a polymer carrier
PCT/EP2010/069710 WO2011073234A2 (en) 2009-12-15 2010-12-15 Growth hormone composition

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US (4) US9511122B2 (sl)
EP (1) EP2512450B1 (sl)
JP (1) JP2013513647A (sl)
CN (2) CN102711733A (sl)
AU (1) AU2010332958B2 (sl)
BR (1) BR112012014721B1 (sl)
CA (1) CA2783296C (sl)
DK (1) DK2512450T3 (sl)
ES (1) ES2667025T3 (sl)
HK (1) HK1214948A1 (sl)
HU (1) HUE038405T2 (sl)
IL (1) IL219981A (sl)
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